Recall Z-3239-2017 ยท FOX Stand, Infusion
Firefly Medical, Inc.
IVEA Product Part Number 16100 Model 500A
| Date | Sep 7, 2017 (initiated Aug 24, 2017) |
| Status | Terminated |
| Reason | The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit. |
| Root cause | Device Design |
| Action | The recall notification is expected to begin on or before 9/8/17 after pin cap components are received for the corrections. Instructions in the recall notification letter do not include return of recall product. They are to be corrected in the field. If any units are returned, they will be labeled and quarantined until corrected by Firefly Medical personnel or the sub-contracted manufacturer supplier. The recall notification letter will be sent certified letter with return receipt. |
| Quantity | 570 units |
| Distribution | United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.